Shire Regenerative Medicine: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Shire Regenerative Medicine”, plus 2 PMA decisions, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MGR | Dressing, Wound And Burn, Interactive | 2 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000036 | PMA | DERMAGRAFT | 2001-09-28 |
| P960007 | PMA | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE | 1997-03-18 |
Recalls
openFDA lists no recalls under a recalling firm named Shire Regenerative Medicine.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Shire Regenerative Medicine is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01891760: Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (Completed, started 2010-05)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shire Biologics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shire Regenerative Medicine?
FDA lists 0 510(k) clearances under the applicant name “Shire Regenerative Medicine”, plus 2 PMA decisions, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Shire Regenerative Medicine?
The most frequent FDA product codes under this applicant name are MGR (Dressing, Wound And Burn, Interactive, 2).
Next steps
- See all 0 Shire Regenerative Medicine clearances with predicates and recalls
- Run predicate analysis for product code MGR, Shire Regenerative Medicine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.