LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931
FDA premarket approval P910073/S046 · decided 2004-07-06
Approval details
- PMA number
- P910073
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Trade name
- LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-06-14
- Decision date
- 2004-07-06
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE SUPPLIER FOR THE MOLD RELEASE, A CHANGE IN THE TYPE OF LUBRICANT, AND A CHANGE IN THE PROCESS OF APPLYING THE LUBRICANT.
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