FLEXTEND BIPOLAR ELUTING EXTENDABLE/RETRACTABLE PACING LEADS,MODELS 4086, 4087, 4088
FDA premarket approval P960006/S035 · decided 2012-10-03
Approval details
- PMA number
- P960006
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXTEND BIPOLAR ELUTING EXTENDABLE/RETRACTABLE PACING LEADS,MODELS 4086, 4087, 4088
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2012-09-04
- Decision date
- 2012-10-03
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
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